Uniformity of Dosage Unit

Assay of LH0003 = 97.80 T= 100.0 %

Limits: = 90.0% --------------- 110.0%
Stage 1 Stage 2
Unit No: Wt (mg) Results Unit No: Wt (mg) Results Unit No: Wt (mg) Results
10 Units 10 Units 10 Units
1 325.50 100.01 11 21
2 315.70 97.00 12 22
3 318.00 97.70 13 23
4 316.10 97.12 14 24
5 316.50 97.24 15 25
6 319.10 98.04 16 26
7 317.40 97.52 17 27
8 314.90 96.75 18 28
9 321.30 98.72 19 29
10 318.60 97.89 20 30
Average weight 318.31 Average weight 318.31
Standerd Deviation 0.9655 Standerd Deviation 3.1423
K 2.4 K 2
M 98.5 M #REF!
X 97.80 X 97.80
│M-X│ 0.70 │M-X│ #REF!
AV =│M-X│+ ks 3.02 AV =│M-X│+ ks #REF!
L1 = 15 %
L2 = 25 %
L1 Acceptance value of 10 units is less than or equal to 15.0%
L2 Acceptance value of 30 units is less than or equal to 25.0% and no unit is ouside
73.88 and 123.13
[(1-L2 x 0.01)M---(1+L2 x 0.01)M]
Stage 1: Acceptance value (AV) of 10 units is less than 15.0
Result: Complies
Stage 2: Acceptance value (AV) of 30 units is less than 25.0
Not required
Result: #REF!
Uniformity of Dosage Unit
Assay of LH0003 = 103.10 T= 100.0 %
Limits: = 90.0% --------------- 110.0%
Stage 1 Stage 2
Wt (mg) Wt (mg) Wt (mg)
Unit No: 10 Units Results Unit No: 10 Units Results Unit No: 10 Units Results

1 310.80 101.76 11 21
2 316.10 103.50 12 22
3 317.30 103.89 13 23
4 316.90 103.76 14 24
5 312.20 102.22 15 25
6 323.70 105.98 16 26
7 313.70 102.71 17 27
8 317.21 103.86 18 28
9 308.50 101.01 19 29
10 312.50 102.32 20 30
Average weight 314.89 Average weight 314.89
Standerd Deviation 1.4071 Standerd Deviation 4.2977
K 2.4 K 2
M 98.5 M #REF!
X 103.10 X 103.10
│M-X│ 4.60 │M-X│ #REF!
AV =│M-X│+ ks 7.98 AV =│M-X│+ ks #REF!
L1 = 15 %
L2 = 25 %
L1 Acceptance value of 10 units is less than or equal to 15.0%
L2 Acceptance value of 30 units is less than or equal to 25.0% and no unit is ouside
73.88 and 123.13
[(1-L2 x 0.01)M---(1+L2 x 0.01)M]
Stage 1: Acceptance value (AV) of 10 units is less than 15.0
Result: Complies
Stage 2: Acceptance value (AV) of 30 units is less than 25.0
Not required
Result: #REF!
Uniformity of Dosage Unit
Assay of LH0003 = 102.80 T= 100.0
Limits: = 90.0% --------------- 110.0%
Stage 1 Stage 2
Wt (mg) Wt (mg)
Unit No: 10 Units Results Unit No: 10 Units
1 516.40 103.82 11
2 514.00 103.34 12
3 508.30 102.19 13
4 510.90 102.71 14
5 514.50 103.44 15
6 511.30 102.79 16
7 511.10 102.75 17
8 508.10 102.15 18
9 508.90 102.31 19
10 509.80 102.49 20
Average weight 511.33
Standerd Deviation 0.5646
K 2.4
M 98.5
X 102.80
│M-X│ 4.30
AV =│M-X│+ ks 5.66
L1 = 15 %
L2 = 25 %
L1 Acceptance value of 10 units is less than or equal to 15.0%
L2 Acceptance value of 30 units is less than or equal to 25.0% and no unit is
73.88 and 123.13
[(1-L2 x 0.01)M---(1+L2 x 0.01)M]
Stage 1: Acceptance value (AV) of 10 units is less than 15.0
Result: Complies
Stage 2: Acceptance value (AV) of 30 units is less than 25.0
Not required
Result: #REF!
 %

Wt (mg)
Results Unit No: 10 Units Results

21
22
23
24
25
26
27
28
29
30
Average weight 511.33
Standerd Deviation 2.8083
K 2
M #REF!
X 102.80
│M-X│ #REF!
AV =│M-X│+ ks #REF!

or equal to 15.0%
or equal to 25.0% and no unit is ouside

V) of 10 units is less than 15.0

V) of 30 units is less than 25.0